WO2023029191A1 - Dispositif d'électrode et système de génération d'onde de choc - Google Patents

Dispositif d'électrode et système de génération d'onde de choc Download PDF

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Publication number
WO2023029191A1
WO2023029191A1 PCT/CN2021/127395 CN2021127395W WO2023029191A1 WO 2023029191 A1 WO2023029191 A1 WO 2023029191A1 CN 2021127395 W CN2021127395 W CN 2021127395W WO 2023029191 A1 WO2023029191 A1 WO 2023029191A1
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WIPO (PCT)
Prior art keywords
electrode
electrodes
catheter
conduction
space
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Ceased
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PCT/CN2021/127395
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English (en)
Chinese (zh)
Inventor
常杰
卜林鹏
程增兵
林林
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Suzhou Hui Healthcare Technology Co Ltd
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Suzhou Hui Healthcare Technology Co Ltd
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Publication of WO2023029191A1 publication Critical patent/WO2023029191A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/22022—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement using electric discharge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing

Definitions

  • the invention belongs to the technical field of medical equipment, and in particular relates to an electrode device and a shock wave generating system.
  • Cardiovascular stenosis refers to human arteriovenous blood vessels, including coronary arteries, peripheral blood vessels, and intracranial blood vessels. Due to abnormal lipid metabolism, lipids in the blood are deposited on the smooth intima of blood vessels, and gradually accumulate into atherosclerosis. Lipid plaques, as time goes by, these plaques increase or even calcify, causing narrowing of the blood vessel lumen, blocking blood flow, leading to downstream blood vessel and body ischemia, and corresponding clinical manifestations. If the stenosis occurs in the coronary artery, it will cause palpitations, chest pain, dyspnea, and angina pectoris.
  • the catheter includes a main tube, and one end of the catheter is connected to the energy generation controller. One end of the balloon is connected.
  • the balloon mainly includes a balloon body, an inner tube, and an electrode pair.
  • the inner tube is arranged inside the balloon body.
  • the energy generation controller can send out and regulate a vibration signal of a specific frequency to make the electrode pair generate a shock wave.
  • the electrodes of the electrode pair in the balloon are ring-shaped, and the overall conduction is equivalent to countless points in parallel. It is impossible to know which area on the electrode generates the shock wave, and it is impossible to control the area where the shock wave is generated.
  • the electrode pair in the balloon It needs to be connected to the energy generation controller through wires. On the one hand, the wiring is complicated; Large, when used in certain lesion sites with small blood vessels, the catheter with too large outer diameter cannot reach the lesion site smoothly, which weakens the effect of the system on lesion treatment.
  • the object of the present invention is to provide an electrode device and a shock wave generating system for treating vascular calcification lesions, which are used to solve the problem that the region and direction of shock waves cannot be controlled.
  • An electrode device includes a catheter and an electrode unit, the electrode unit includes a plurality of electrodes, the electrode device also includes an annular member disposed outside the catheter around the circumference of the catheter, the plurality of electrodes are arranged along the The circumferential distribution of the catheter, each of the electrodes is respectively passed through the ring member or between the ring member and the catheter, and keeps part of the peripheral surface exposed, and one or more electrodes are formed on the ring member A conduction space, the conduction space is used to connect the exposed peripheral surface of two adjacent electrodes with the space outside the electrode device, so that when the electrode device is connected to electricity, in the A shock wave is formed inside the conduction space and released outward from the opening of the conduction space.
  • the electrode unit includes a positive electrode for connecting to a positive electrode, a negative electrode for connecting to a negative electrode, and one or more intermediate electrodes, the positive electrode and the negative electrode are arranged adjacent to each other and insulated from each other, the The conduction space is respectively provided between the positive electrode and the intermediate electrode, and between the negative electrode and the intermediate electrode. When there are multiple intermediate electrodes, a space is also formed between two adjacent intermediate electrodes. There is the conduction space.
  • the positive electrode and the negative electrode are respectively one, and the intermediate electrodes are 1, 2, 3, 4, 5, 6 or more, further Preferably, the total number of positive electrodes, negative electrodes and intermediate electrodes is 3-10.
  • one or more conduction spaces are provided between two adjacent electrodes.
  • the directions are set, and the plurality of conducting spaces are independent of each other.
  • a plurality of the conduction spaces are distributed along the circumference of the catheter; viewed from the longitudinal section of the electrode device, the plurality of conduction spaces are within the length of the electrode device.
  • the same position in the direction or in different length positions, or part of the conduction spaces are in the same position in the length direction of the electrode device, and part of the conduction spaces are in different length positions.
  • the conduction space is filled with conductive liquid, and the current passes through the positive electrode, one or more intermediate electrodes, and negative electrodes in sequence to form a current path.
  • the ratio of the exposed surface of each electrode to the surface area of the electrode is greater than 0 and less than 100%.
  • the ring-shaped member includes an insulating sleeve
  • the insulating sleeve has a connecting hole in the middle and is used for socketing the conduit
  • the insulating sleeve is also provided with a plurality of perforations extending along its length direction, and a plurality of Perforations are distributed around the connecting holes
  • the plurality of electrodes pass through the plurality of perforations respectively
  • the insulating sleeve is formed with a groove opening outward on at least one side of the through holes, and the grooves are connected to the plurality of through holes.
  • the through-holes are opened, so that at least part of the surface of the electrode located in the through-holes is exposed, and the internal space of the groove forms the conduction space.
  • the diameter of the perforation is smaller than the wall thickness of the insulating sleeve, and the depth of the groove is smaller than or equal to the wall thickness of the insulating sleeve.
  • the insulating sheath includes a sheath body made of non-conductive material; or, the insulating sheath includes a sheath body and an insulating coating provided on the surface of the sheath body.
  • the ring member is an integral molding.
  • the annular member includes an annular sleeve body and a filling body, the sleeve body is sleeved outside the catheter, the filling body is filled between the sleeve body and the catheter, the sleeve body, the filling body
  • the same part of the body is provided with a groove with an opening facing outward, so that at least part of the surface of the electrode is exposed at the opening, and the inner space of the groove forms the conduction space.
  • the conduit has two ends that are relatively far away, and the annular member is disposed close to one of the two ends.
  • one or more ring members are provided, and when multiple ring members are provided, the plurality of ring members are distributed along the axial direction of the catheter; the electrodes are elongated, and each electrode The electrodes are respectively passed through the annular member or between the annular member and the catheter along its length direction, and further preferably, the electrodes are parallel to the catheter.
  • multiple electrodes of one electrode unit are evenly distributed around the catheter.
  • the cross-section of the catheter is circular or polygonal, or the catheter is provided with grooves for placing the electrodes along its axial direction.
  • An electrode device comprising a catheter and an electrode unit, the electrode unit including a plurality of electrodes, characterized in that: the electrode device also includes an annular member surrounding the circumference of the catheter and arranged outside the catheter, the plurality of electrodes Two electrodes are distributed along the circumferential direction of the catheter, and each electrode is respectively penetrated in the annular member or between the annular member and the catheter, and keeps part of the peripheral surface exposed, and on the annular member One or more conduction spaces are formed, and the conduction spaces are used to connect the exposed peripheral surfaces of two adjacent electrodes with the space outside the electrode device, so that when the conduction spaces are filled with When the conductive liquid is connected to the electrode device, a shock wave is formed in the conducting space and the shock wave is released from the opening of the conducting space;
  • the electrode unit includes a positive electrode for connecting the positive electrode, a negative electrode for connecting the negative electrode, and one or more intermediate electrodes, the positive electrode and the negative electrode are adjacently arranged and insulated from each other, the positive electrode
  • the conduction space is respectively provided between the intermediate electrode, the negative electrode and the intermediate electrode, and when there are multiple intermediate electrodes, the conduction space is also formed between two adjacent intermediate electrodes;
  • the current passes through the positive electrode, one or more intermediate electrodes, and the negative electrode in sequence to form a current path;
  • the ring member includes an insulating sleeve, the insulating sleeve has a connecting hole in the middle and is used to sleeve the conduit, and a plurality of perforations extending along its length are also provided on the insulating sleeve, and the plurality of perforations surround the The distribution of the connection holes, the plurality of electrodes correspondingly pass through the plurality of through holes, the insulating sleeve is formed on at least one side of the through holes with an opening facing outwards, and the gap between the grooves and the through holes Opening between them, so that at least part of the surface of the electrode located in the through hole is exposed, and the internal space of the groove forms the conduction space;
  • the annular member includes an annular sleeve body and a filling body, the sleeve body is sleeved outside the catheter, the filling body is filled between the sleeve body and the catheter, the sleeve body, the filling body A groove with an opening facing outward is opened at the same position, so that at least part of the surface of the electrode is exposed at the opening, and the inner space of the groove forms the conduction space.
  • a shock wave generation system includes an electrode device and a balloon, and the insulating sleeve is located in the balloon.
  • the present invention has the following advantages compared with the prior art:
  • the present invention can generate specific directional shock waves by arranging ring members and electrode units, and opening conduction spaces on the ring members, and can control the generation of shock waves by adjusting the position, shape, quantity, and size of the conduction spaces on the ring members.
  • the position, direction and size can achieve the best shock wave effect;
  • the ring member can limit the movement of the electrode unit to ensure the stability of the position, direction and shape of the conduction space, and the overall installation is more stable, and the discharge of the catheter is more stable and safer; and the structure is simple Easy to implement.
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.
  • the electrode device shown in Figures 1 to 12 includes a catheter 1, an electrode unit and a ring member 2, the ring member 2 is an insulator, wherein: the ring member 2 surrounds the catheter 1 and is arranged outside the catheter 1, a plurality of electrodes Distributed along the circumferential direction of the catheter 1, each electrode is respectively passed through the ring member 2 or between the ring member 2 and the catheter 1, and keeps part of the peripheral surface exposed, and the ring member 2 is formed with one or more Or axially distributed conduction space 21, the conduction space 21 is used to connect the exposed peripheral surface of two adjacent electrodes and the space outside the electrode device, so that when the conduction space 21 is filled with conductive liquid and the electrodes When the device is powered on, a shock wave is formed in the conduction space 21 and released from the opening of the conduction space 21 to generate a shock wave in a specific direction to treat a specific lesion.
  • the conductive liquid can be a mixed solution of contrast fluid and physiological saline.
  • the catheter 1 has two ends that are relatively far away, and the ring member 2 is arranged close to one of the two ends, one of which is close to the lesion. When in use, the ring member 2 is close to the lesion. near one end.
  • the exposed surface of the electrode means that the conductive part of the electrode is exposed at the opening of the conduction space.
  • the conduction space is filled with a conductive liquid, the exposed surface of the electrode can contact the conductive liquid.
  • the ratio of the exposed surface of each electrode to the surface area of the electrode is greater than 0 and less than 100%, the range can be 1%-70%, such as 10%, 20%, 30%, 40%, 50%, 60% or 70%, etc., can produce different intensities of shock waves, and can adapt to different lesion locations .
  • One or more conduction spaces 21 between adjacent two electrodes are arranged on the same length direction of the electrode device, when the conduction space 21 between adjacent two electrodes is arranged on the same length direction of the electrode device.
  • the number of conduction spaces 21 can be 1, 2 or more than the total number of electrodes, for example, when there are three electrodes, the conduction spaces 21 can be two or one; when there are four electrodes, the conduction spaces 21 can be three, two or one.
  • the electrode has a certain length
  • the annular member 2 can correspond to two adjacent electrode positions and set up a plurality of conduction spaces along the length direction. through space 21, and a plurality of conduction spaces 21 are independent of each other, mutually independent means that there is a gap between two adjacent conduction spaces 21 and no shock wave will be generated between two adjacent conduction spaces 21, see the two adjacent conduction spaces 21 in Fig. 8 A conduction space 21.
  • the quantity of conduction space 21 can be less than 2 or more than the total number of electrodes, and the quantity of conduction space 21 can be greater than or equal to the total number of electrodes, such as when the number of electrodes is two, conduction space 21 is set to two or two more than three; when the number of electrodes is three, three or more conducting spaces 21 can be set; when the number of electrodes is more than three, more than three conducting spaces 21 can be set.
  • a plurality of conducting spaces 21 are provided, as seen from the cross section of the electrode device (as shown in the direction in FIG. 3 ), the plurality of conducting spaces 21 are distributed along the circumferential direction of the catheter 1, and each conducting space 21 is fan-shaped. Square, circular or other arbitrary shapes, see Fig. 1, Fig. 3; Seen from the longitudinal section of the electrode device (along the length direction of the catheter), a plurality of conduction spaces 21 are at the same position in the length direction of the electrode device or at different lengths position ( FIG. 7 ), or part of the conduction space is at the same position in the length direction of the electrode device, and part of the conduction space is at different length positions ( FIG. 8 ). That is, the conduction spaces 21 can be in one interface, or in staggered positions.
  • a corresponding number of electrodes is set, and a corresponding number of conduction spaces 21 can be set according to the number of electrodes, so as to form a plurality of shock wave-generating regions to adapt to different lesions to be treated, and can act on large-area vascular calcified lesions, Thereby fragmenting the calcified plaque and improving the therapeutic effect.
  • a corresponding number of conduction spaces 21 can be set according to the number of electrodes, so as to form a plurality of shock wave-generating regions to adapt to different lesions to be treated, and can act on large-area vascular calcified lesions, Thereby fragmenting the calcified plaque and improving the therapeutic effect.
  • the conduction space 21 can be circular, oval, square, trapezoidal or other achievable shapes, such as the conduction space 21 gradually becomes larger from the inside to the outside, the inner refers to the direction close to the center of the catheter 1, and the outer refers to the direction away from the catheter 1, That is, the opening of the hole near the outside of the catheter 1 is larger than the opening of the hole near the catheter 1, which is convenient for forming a shock wave that gradually spreads outward in the conduction space 21, and the shock wave impacts a larger calcified area to achieve crushing of a larger area. Calcified lesions.
  • the location, shape and size of the conduction space 21 can be varied to control the location, direction and/or size of shock wave generation.
  • the position of the conduction space 21 can be changed by changing the position of the electrode. When the position of the electrode remains unchanged, the conduction space 21 can be opened at different positions of the ring member 2 to adapt to different lesion positions.
  • the ring member 2 is an insulating part, and its specific structure is as follows:
  • the insulating sleeve has a connecting hole 24 located in the middle and used to sleeve the catheter 1, and a plurality of perforations 23 extending along its length direction are also provided on the insulating sleeve (each electrode is respectively along its length.
  • Direction is set in the ring member 2 in the corresponding perforation 23, one perforation 23 places one electrode), multiple perforations 23 are distributed around the connecting hole 24, multiple electrodes respectively pass through multiple perforations 23, and the insulating sleeve is located in the perforation 23
  • At least one side of the groove is formed with a groove opening outward, and the groove and the through hole 23 are opened, so that at least part of the surface of the electrode in the through hole 23 is exposed, and the internal space of the groove forms a conducting space 21 .
  • the aperture of the perforation 23 is less than the wall thickness of the insulating sleeve, the depth of the groove is less than or equal to the wall thickness of the insulating sleeve, and the bottom of the groove extends to the perforation 23, at this time, the depth of the groove is less than the wall thickness of the insulating sleeve; or, the bottom of the groove can extend to The outer wall of the conduit 1, at this time the depth of the groove is equal to the wall thickness of the insulating sleeve.
  • each electrode is respectively installed in the annular member 2 .
  • the ring member 2 is a solid structure between the outside and the connection hole 24.
  • the electrodes are in the perforations 23 (if there are positive electrodes 3 and negative electrodes 4 in the two perforations 23 respectively, the two perforations 23 with the positive electrodes 3 and the negative electrodes 4 are placed in the two ends along the length direction of the two perforations.
  • the diameter of the electrode is slightly smaller than the diameter of the perforation 23, and the electrode can not shake in the perforation 23, and the position is fixed. Or the electrodes are penetrated into the perforations 23 and then filled with insulating glue for bonding. When in use, the glue on the electrodes exposed at the conduction space 21 is removed before being energized and used.
  • the above-mentioned insulating sleeve includes a sleeve body made of non-conductive material, and the sleeve body is an integrally formed part, such as a structural part formed by injection molding or other molding methods, or a glue-like substance such as epoxy glue or ultraviolet curing glue. Shaped structural parts made of molds with corresponding appearance.
  • the insulating sleeve is a coating formed on the electrode, and the insulating sleeve is made of insulating jelly.
  • the electrode is fixedly placed on the outside of the catheter 1 (such as bonding), and then the insulating jelly Coating on the outside of the electrode to form a sleeve, such as covering the electrode with a predetermined length, so that the electrode cannot be exposed.
  • the insulating jelly is solidified, slot the insulating jelly (remove the material), so that the electrode has at least Part of the surface is exposed at the opening of the groove, and the inner space of the groove forms a conducting space 21 .
  • the electrodes are arranged between the insulating sheath and the catheter 1 .
  • the insulating sleeve includes a sleeve body and an insulating coating on the surface of the sleeve body. Perforations and grooves can be provided on the sleeve body.
  • the sleeve body is made of high-strength materials or non-conductive materials. This structure has high strength and impact resistance. powerful.
  • the non-conductive material is polyimide, epoxy glue or ultraviolet curing glue, and the high-strength material is selected from metal.
  • the casing is made of high-strength material, the inner wall of the conduction space 21 and the inner wall of the perforation 23 are coated with an insulating coating.
  • the sleeve body has a connection hole 24 located in the middle and is used to sleeve the catheter 1.
  • the sleeve body is also provided with a plurality of perforations 23 extending along its length direction.
  • the plurality of perforations 23 are distributed around the connection hole 24.
  • the plurality of electrodes are respectively Correspondingly passing through a plurality of perforations 23, the sleeve body is formed with a groove with an opening facing outward on at least one side of the perforation 23, and the groove and the perforation 23 are opened, so that at least part of the surface of the electrode located in the perforation 23 is exposed, and the groove
  • the inner space forms a conduction space 21 .
  • the annular member 2 includes an annular sleeve body 25 and a filling body 26, the annular sleeve body 25 and the filling body 26 are all made of non-conductive materials, the sleeve body 25 is sleeved outside the catheter 1, and the filling body 26 is filled between the sleeve body 25 and the catheter 1 In between, grooves are opened again, that is, the corresponding parts of the sleeve body 25 and the filling body 26 are provided with grooves opening outward, so that at least part of the surface of the electrode is exposed at the opening of the groove, and the internal space of the groove forms a conduction space 21.
  • the sleeve body 25 is hollow and annular, that is, its outer wall is very thin and has a connecting hole 24 for the catheter 1 to pass through.
  • a filling body 26 is filled between the sleeve body 25 and the electrodes (such as filling an insulating gel to form a filling body 26), so that The electrodes in the sleeve body 25 are covered by an insulating material, and then the same part of the sleeve body 25 and the filling body 26 are grooved (the material at the same position is removed), so that at least part of the surface of the electrode is exposed at the opening, and the inner space of the groove The conduction space 21 is formed.
  • the electrodes are arranged between the annular member 2 and the catheter 1 .
  • the ring member 2 is in a closed ring shape, such as a circular ring, a polygonal ring (such as a square ring, a triangular ring), an elliptical ring or any other shape; or the ring member 2 is in a non-closed ring shape, such as a C-shaped ring with a gap.
  • a closed ring shape such as a circular ring, a polygonal ring (such as a square ring, a triangular ring), an elliptical ring or any other shape; or the ring member 2 is in a non-closed ring shape, such as a C-shaped ring with a gap.
  • the thickness of other parts of the annular member 2 is uniform or uniform, which does not affect the use.
  • the arrangement of the ring member 2 can limit the movement of the electrode, ensure the position and shape of the conduction space 21 are stable, and the overall installation is more stable, and the discharge of the electrode device is more stable and safer when used.
  • the cross-section of the catheter 1 is circular or polygonal (pentagonal, hexagonal).
  • the catheter 1 can be conventionally extruded into a circular tube, or the catheter 1 is provided with a plurality of grooves for placing electrodes along its axial direction. 11 (recessed toward the center of the catheter 1), that is, an electrode is placed in each groove 11, which is convenient for wiring and easy to correspond to the conduction space 21 on the ring member 2.
  • the catheter 1 is made of polyurethane, Pebax (polyether block polyamide), FEP (perfluoroethylene propylene copolymer), nylon, polyimide or PTFE (polytetrafluoroethylene).
  • the electrode is made of metal, conductive glue or graphene, wherein the metal is selected from gold, silver, copper, tantalum, stainless steel, tungsten alloy or platinum-iridium alloy, preferably stainless steel.
  • the electrodes can be in various shapes such as strips, balls, etc., such as flat or round.
  • a plurality of electrodes are distributed along the circumferential direction of the catheter, and each electrode is respectively installed in the ring member 2 or between the ring member 2 and the catheter 1.
  • the electrodes and the catheter 1 are preferably parallel, and the structure is simple and convenient. Installation is convenient for the annular member 2 to be arranged outside the catheter 1 and the conduction space 21 on it is aligned with the corresponding electrode, which facilitates the design and control of the conduction space 21 .
  • the electrodes are elongated, which are metal wires, metal rods, metal spring bars, metal tubes or metal spring tubes, the electrodes can be of the same material or of different materials.
  • the diameter range of the electrode is 0.05-1.0mm, the thickness of the ring member 2 is slightly larger than the diameter of the electrode, the overall diameter of the ring member 2, the electrode and the catheter 1 is within 1-3mm, and the overall outer diameter does not increase too much, which does not affect the electrode Applicability of the device to any lesion site.
  • the exposed surface of the electrode is exposed at the opening of the conduction space 21 .
  • the surface of the electrode is provided with an insulating layer.
  • the insulating layer of the electrode corresponds to the conduction space 21.
  • a hole is opened to remove a part of the insulating layer, so that the exposed surface of the electrode is exposed (that is, the exposed electrode part without insulation).
  • the insulating layer is an insulating coating or an insulating tube respectively sleeved outside the electrodes, that is, one insulating tube can be sleeved on one electrode.
  • the insulating skin is the insulating layer outside the metal conductor
  • the insulating skin is removed to expose the metal conductor (that is, the inner core wire, such as copper wire).
  • the inner core wire opens in the conduction space Exposure
  • the wire gauge is preferably AWG10-AWG46, AWG (American wire gauge) American wire gauge, is a standard for distinguishing wire diameters.
  • the working principle of the shock wave generated by the conduction space 21 is as follows: the electrode itself is a conductor, and when the electrode device is working, the conduction space 21 is filled with a conductive liquid, and the exposed surfaces of the two adjacent electrodes can be immersed in the conductive liquid. Positive and negative voltages are applied to two electrodes respectively. When the voltage reaches a certain value, the conductive liquid in the conduction space 21 is broken down, resulting in a cavitation effect, and the current passes through one electrode and the other electrode to form a current path to generate shock waves. Fragmentation of plaque in stenotic locations to treat vascular calcification lesions.
  • the electrode unit includes a positive electrode 3 for connecting the positive pole and a negative electrode 4 for connecting the negative pole.
  • the positive electrode 3 and the negative electrode 4 are adjacently arranged (not in contact) and mutually insulated.
  • the positive electrode 3 and the negative electrode 4 There is a conduction space 21 between them, see FIG. 1 and FIG. 2 .
  • the electrode unit includes a positive electrode 3 for connecting to a positive electrode, a negative electrode 4 for connecting to a negative electrode, and one or more intermediate electrodes 5 .
  • the positive electrode 3 and the negative electrode 4 are adjacently arranged (not in contact) and insulated from each other, for example, they are isolated and insulated by the insulating structure 22 of the ring member 2 .
  • a conduction space is respectively provided between the positive electrode 3 and the intermediate electrode, and the negative electrode 4 and the intermediate electrode. When there are multiple intermediate electrodes, a conduction space is also formed between two adjacent intermediate electrodes.
  • the positive electrode 3 is connected to the positive pole of the energy generating unit 6, and the negative electrode 4 is connected to the negative pole of the energy generating unit 6.
  • the intermediate electrode 5 does not need to be connected to the energy generating unit 6.
  • the electric current passes through the positive electrode, one or A plurality of intermediate electrodes and negative electrodes form a current path, and a plurality of intermediate electrodes 5 can be arranged to form a corresponding number of conduction spaces 21 in the circumferential direction of the ring member 2, so as to form a plurality of regions for generating shock waves, so as to adapt to different lesions to be treated parts.
  • each electrode unit there are one positive electrode 3 and one negative electrode 4, and one, two, three, four, five, six or more intermediate electrodes 5.
  • one positive electrode 3, negative electrode 4, and intermediate electrode 5 are provided, one or more conducting spaces 21 are formed between the positive electrode 3 and the intermediate electrode 5 in the length direction of the electrode device, and the negative electrode 4 and the intermediate electrode 5 One or more conduction spaces 21 are formed between them in the length direction of the electrode device.
  • a conduction space 21 is also formed between two adjacent intermediate electrodes 5 .
  • the total number of positive electrodes 3, negative electrodes 4, and intermediate electrodes 5 may be 3-10.
  • the working principle of shock waves generated in the conduction space 21 is as follows: the positive electrode 3, the negative electrode 4 1.
  • the middle electrode 5 itself is a wire (conductor).
  • the conductive liquid was filled in the conduction space 21, and the exposed surfaces of the adjacent two electrodes could be immersed in the conductive liquid. 4 Apply positive and negative voltages respectively.
  • the voltage reaches a certain value, the conductive liquid in the conduction space 21 is broken down, resulting in a cavitation effect, and the current passes through the positive electrode 3, one or more intermediate electrodes 5, and the negative electrode 4 in sequence.
  • a current path is formed, a shock wave is formed in the conduction space, and the shock wave is released from the opening of the conduction space, so as to achieve plaque fragmentation at the narrow position and treat the vascular calcification lesion position.
  • the length of the intermediate electrode 5 is less than or equal to the axial length of the ring member 2 , and the intermediate electrode 5 does not need to be connected to the energy generating unit 6 , but only needs to be placed in the corresponding through hole 23 .
  • the length of the positive electrode 3 and the negative electrode 4 is less than or greater than the axial length of the ring member 2 .
  • a plurality of electrode units are arranged along the axial direction of the catheter 1, and a large number of conducting spaces 21 are formed in the axial or circumferential direction of the catheter 1 to act on a large area of vascular calcified diseased blood vessels, thereby causing calcified plaque fragmentation , improve the therapeutic effect.
  • multiple electrodes are preferably evenly distributed around the catheter 1, so that the formed conduction space 21 is evenly distributed around the catheter 1, and the generated shock waves can act on vascular calcification lesions more evenly.
  • a plurality of ring members 2 are arranged along the axial direction of the catheter 1, and each ring member 2 is pierced with a plurality of electrodes or is provided with a plurality of electrodes between each ring member 2 and the catheter 1, and between two adjacent ring members 2 A gap or contact can be maintained between them, and a plurality of conduction spaces 21 can be formed in the axial direction of the catheter 1 on the plurality of ring members 2 to generate a large range of shock waves. It can treat large-area calcified blood vessels, that is, it is not necessary to send the catheter 1 to more internal lesion sites multiple times, and the operation time can be greatly reduced.
  • a shock wave generating system referring to Fig. 13 and Fig. 14, includes an electrode device, an energy generating unit 6, and a balloon 7, the annular member 2 is located in the balloon 7, and one or more conduction spaces 21 are formed on the annular member 2, The conduction space 21 communicates with the annular member 2, and when the balloon 7 is filled with conductive liquid, the conduction space 21 is filled with the conductive liquid.
  • the electrode device includes a catheter 1 and an electrode unit, and the electrode unit includes a plurality of electrodes, one electrode is used to connect with the positive pole of the energy generating unit 6, and one electrode is connected with the negative pole of the energy generating unit 6.
  • the system also includes a handle 8.
  • the handle 8 is arranged on the catheter 1.
  • the handle 8 is connected to the energy generating unit 6 for controlling the operation of the energy generating unit 6.
  • the catheter 1 in the balloon 7 is covered with a plurality of indicators for indicating the length. Mark ring 9.
  • the electrode unit includes a positive electrode 3 for connecting the positive pole and a negative electrode 4 for connecting the negative pole, the positive electrode 3 and the negative electrode 4 are adjacently arranged (not in contact), and the positive One side between the electrode 3 and the negative electrode 4 is insulated, and the other side is provided with a conduction space 21.
  • the positive electrode 3 and the negative electrode 4 are separated by 90 degrees in the circumferential direction; in FIG. 2, the positive electrode 3 , The negative electrodes 4 are separated by 180 degrees in the circumferential direction.
  • the annular member 2 is an insulating sleeve, and only one positive electrode 3, negative electrode 4, and intermediate electrode 5 are provided, and the positive electrode 3 and the negative electrode 4 are adjacently arranged with one side between them They are insulated from each other, the middle electrode is arranged on the other side between the two, and the positive electrode 3, the middle electrode 5, and the negative electrode 4 are separated by 120 degrees in the circumferential direction.
  • a conduction space 21 is formed between the positive electrode 3 and the adjacent intermediate electrode 5, and between the negative electrode 4 and the adjacent intermediate electrode 5, that is, two conduction spaces 21 are provided on the ring member 2, Shock waves (energy release) can be generated in the two conducting spaces 21 .
  • This embodiment is basically the same as Embodiment 2, the difference is:
  • only one positive electrode 3 and negative electrode 4 are provided, two intermediate electrodes are provided, and the positive electrode 3 and negative electrode 4 are adjacently arranged with one side between them.
  • the middle electrode is arranged on the other side between the two, and the positive electrode 3, the middle electrode 51, the middle electrode 52, and the negative electrode 4 are separated by 90 degrees in the circumferential direction.
  • the conduit 1 is a round pipe, and the annular member 2 is an insulating sleeve; in Fig. 5, the conduit 1 is provided with four grooves 11, and the annular member 2 is an insulating sleeve; among Fig. 6, the conduit 1 is a round pipe, and the annular member 2 includes Cover the main body 25 and the filling body 26; in FIG.
  • two independent conduction spaces 21 are formed between the positive electrode 3 and the intermediate electrode 51, and the two independent conduction spaces 21 are arranged along the axial direction of the ring member 2, correspondingly , Two independent conducting spaces 21 can be formed between the negative electrode 4 and the intermediate electrode 52, and two independent conducting spaces 21 can be formed between the intermediate electrode 51 and the intermediate electrode 52, which are not shown on the back of FIG. 8 .
  • the conduction spaces 21 are formed between the negative electrode 4 and the adjacent intermediate electrode 52, and between two adjacent intermediate electrodes (51, 52), And the positive electrode 3 is connected with the intermediate electrode 51 adjacent thereto by a wire (during the work of the electrode device, the negative electrode 4 is connected with the negative pole, the positive electrode 3 is connected with the positive pole, or the intermediate electrode 51 is connected with the positive pole, or the positive electrode 3 is connected with the positive pole.
  • the wiring between the intermediate electrode 51 is connected to the positive pole); or, if the positive electrode 3 is connected to the adjacent intermediate electrode 51, or between two adjacent intermediate electrodes (51, 52), a conduction space 21 is formed.
  • the negative electrode 4 and the adjacent intermediate electrode 52 are connected by wires; or, if the positive electrode 3 and the adjacent intermediate electrode 51, the negative electrode 4 and the adjacent intermediate electrode 52 Conducting spaces 21 are formed between them, and two adjacent intermediate electrodes (51, 52) are connected by wires.
  • the current passes through the positive electrode 3 , the middle electrode 51 , the middle electrode 52 , and the negative electrode 4 in order to form a current path, so that the current flows clockwise and counterclockwise and breaks down.
  • This embodiment is basically the same as Embodiment 2, the difference is:
  • the annular member 2 is an insulating sleeve, only one positive electrode 3 and negative electrode 4 are provided, three intermediate electrodes are provided, and the positive electrode 3 and negative electrode 4 are adjacently arranged with a gap between them.
  • One side is insulated from each other, and the middle electrode is arranged on the other side between the two.
  • the positive electrode 3, the middle electrode 51, the middle electrode 52, the middle electrode 53, and the negative electrode 4 are separated by 72 degrees in the circumferential direction.
  • the catheter 1 is round tube.
  • This embodiment is basically the same as Embodiment 2, the difference is:
  • the annular member 2 is an insulating sleeve, only one positive electrode 3 and negative electrode 4 are provided, four intermediate electrodes are provided, and the positive electrode 3 and negative electrode 4 are adjacently arranged with a gap between them.
  • One side is insulated from each other, and the middle electrode is arranged on the other side between the two.
  • the positive electrode 3, the middle electrode 51, the middle electrode 52, the middle electrode 53, the middle electrode 54, and the negative electrode 4 are separated by 60 degrees in the circumferential direction.
  • Conduit 1 is a round tube.
  • the positive electrode 3 and the adjacent intermediate electrode 51, and/or the negative electrode 4 and The adjacent intermediate electrode 54, and/or between two adjacent intermediate electrodes can form a corresponding number of conduction spaces 21 through wire connection, and can realize the control of the position and quantity of the conduction spaces 21.

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Abstract

La présente invention concerne un dispositif d'électrode et un système de génération d'onde de choc. Le dispositif d'électrode comprend un cathéter et une unité d'électrode, l'unité d'électrode comprenant une pluralité d'électrodes. Le dispositif d'électrode comprend en outre un élément annulaire disposé à l'extérieur du cathéter et autour de la circonférence du cathéter. La pluralité d'électrodes sont réparties le long de la circonférence du cathéter ; et chaque électrode est disposée dans l'élément annulaire de manière pénétrante ou est disposée entre l'élément annulaire et le cathéter, et une partie d'une surface circonférentielle de chaque électrode reste exposée. Un ou plusieurs espaces de conduction sont formés dans l'élément annulaire, et l'espace de conduction est utilisé pour faire communiquer les surfaces circonférentielles exposées de deux électrodes adjacentes avec un espace extérieur au dispositif d'électrodes, de sorte que lorsque l'espace de conduction est rempli d'un liquide conducteur et que le dispositif d'électrode est mis sous tension, une onde de choc est formée dans l'espace de conduction, et l'onde de choc est libérée vers l'extérieur via une ouverture de l'espace de conduction. Selon la présente invention, la position, la direction et l'amplitude d'une onde de choc sont contrôlées en fournissant l'unité d'électrode et l'élément annulaire et en ajustant de manière coopérative l'espace de conduction dans l'élément annulaire, réalisant ainsi le meilleur effet d'onde de choc.
PCT/CN2021/127395 2021-08-31 2021-10-29 Dispositif d'électrode et système de génération d'onde de choc Ceased WO2023029191A1 (fr)

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